Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Location/Division Specific Information
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our clients to make the world healthier, safer, and cleaner. This is an onsite located Upper Merion, PA.
Summarized Purpose:
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
Essential Fuctions:
Employee will be expected to participate in all aspects of department visual inspection program, including preparation of the inspection suite, stocking of related supplies, performance of inspection of injectable products, completion of associated logbooks and batch documentation, and storage of finished product.
Individual can pass color-blindness and vision testing (must achieve 20/20 with or without vision correction such as glasses or contact lenses).
Must be able to pass visual appearance testing method competencies within 90 days of hire.
When not inspecting, employee will be asked to complete training in and perform functions in manufacturing operations, which may include vial washing, component rinsing and preparation, Container Closure Integrity testing, and other manufacturing tasks as requested.
Employee will also assist with department consumables storage and stocking programs.
Employee may be asked to perform administrative tasks such as procedure revision, template revision, records filing, records archiving, and other tasks as needed.
All job functions will be performed according to procedure and in accordance with cGMP, Standard Operating Procedures, and client safety codes and regulations.
Identifies risks to business for consideration by management.
Assist and contribute to GMP and safety self-inspection activities.
Accountable for delivering innovation in the Clinical Supply Chain to deliver cost savings, reduce risk and improve service.
Accountable for reporting and maintaining metrics as appropriate.
Zero instances of data falsification or data integrity issues by PPD staff.
Employee has basic computer skills including Word, Outlook, and ability to navigate simple website interfaces.
When performing visual inspection, employee will be expected to sit and inspect product for periods of up to one hour with small (5-10 minute) breaks once an hour, for no longer than 8 hours a day.
When performing manufacturing operations, employee will be expected to wear appropriate gowning (scrubs, hair net, beard cover, gloves, safety glasses, safety shoes), stand for periods of time, and operate standard pharmaceutical manufacturing equipment.
Employee must have good hygiene, practice good hand-washing behaviors, and be comfortable frequently using hand sanitizing agents.
When performing manufacturing operations, employee may not wear jewelry, makeup, perfume, nail polish, or have artificial nails. Flat wedding bands and medical alert bracelets are accepted.
Employee may be asked to work occasional overtime hours.
Must be a committed team player prepared to work in and accept a team-based culture.
Education and Experience:
Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
Assoc Scientist level: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years) is equivalent.
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Application of knowledge and leveraging of continuous improvement activities applying available tools where applicable that support continued adherence with industry regulations, Global Quality Policies (GQP 3201A and GQP 3201B) and supporting business procedures.
Proactively communicates the status of critical compliance systems support and problem resolution. Ensures effective problem analysis and resolution of issues of diverse scope in a timely fashion and advances issues when needed to appropriate levels of Sterile Ops management.
Applies metric generation and reporting for Sterile Ops led processes.
Leads by example in working collaboratively and adopting client's Code of Conduct to successfully implement solutions. Develops and maintains mutually productive relationships in the workplace. Builds and demonstrates their own networks of expertise formed with other senior internal and external personnel for the benefit of the team.
Owns the identification and implementation of strategies to improve the qualities and efficiencies of Sterile Ops processes, systems and results. Maintains strong systems/processes understanding of current technologies and professional concepts.
Responsible for scheduling and planning work to meet priorities set by our client. Sets specific daily and weekly priorities to meet timelines. Recommends procedures and policies to supervision.
Working Environment:
Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with
proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Our 4i Values:
Integrity - Innovation - Intensity - Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
